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A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)

This study has been completed.
Sponsor:
Information provided by:
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT00109564
First received: April 28, 2005
Last updated: July 17, 2008
Last verified: July 2008

April 28, 2005
July 17, 2008
January 2005
Not Provided
  • To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
  • To assess effect, on cognition, of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
Same as current
Complete list of historical versions of study NCT00109564 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)

The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Age-Related Memory Disorders
Drug: ispronicline (nicotinic acetylcholine receptor agonist)
Not Provided
Dunbar GC, Kuchibhatla RV, Lee G; TC-1734 (AZD3480) AAMI Clinical Study Group (USA). A randomized double-blind study comparing 25 and 50 mg TC-1734 (AZD3480) with placebo, in older subjects with age-associated memory impairment. J Psychopharmacol. 2011 Aug;25(8):1020-9. Epub 2010 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
October 2005
Not Provided

Inclusion Criteria:

  • Male or female subjects aged 50-80 years.
  • Lives with a significant other.
  • Has subjective memory complaints. Verbal verification of this subjective memory complaint will be obtained from the significant other.
  • Has no severe, uncontrolled medical condition.
  • If receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial.

Exclusion Criteria

  • Aged less than 50 years or greater than 80 years.
  • Lives alone.
  • Has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures.
  • Medication for a medical condition has been changed in the last 2 months or during the trial.
  • Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study.
  • Has evidence of depression or anxiety
  • Meets DSM-IV criteria for Alzheimer's or vascular dementia.
  • Has participated in an investigational drug trial in the previous 30 days.
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109564
TC-1734-112-CRD-004
Not Provided
Not Provided
Targacept Inc.
Not Provided
Not Provided
Targacept Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP